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New Products

Epic Sciences Launches Single-Cell Microsatellite and Chromosomal Instability Genomic Analysis
Markets Insider – Nov 2, 2017
Epic Sciences, Inc. adds simultaneous microsatellite instability (MSI) and chromosomal instability (CIN) measurements, also known as genomic scarring analysis, to the single cell next generation sequencing (NGS) workflow for clinical research of immuno-oncology therapies.

Qiagen Launches New Custom Solutions Business for Molecular Testing
Zenopa- Nov 7, 2017
Qiagen has announced the launch of its new Custom Solutions business, providing a range of new testing services for life science and molecular diagnostics companies. It will provide a range of custom and OEM sample technologies and oligo and enzyme product options for polymerase chain reaction (PCR), qPCR and next-generation sequencing product development, as well as a broad range of other platform technologies.

Vortex Biosciences Announces First Commercial Sale of the VTX-1 Liquid Biopsy System
PR Web – Nov 7, 2017
Vortex Biosciences, provider of circulating tumor cell (CTC) capture systems, announced the first commercial sale of the VTX-1 Liquid Biopsy System, a fully automated benchtop system for collecting intact CTCs. The VTX-1 utilizes proprietary microfluidics to automate the isolation of CTCs directly from whole blood based on the larger size and deformability of the cells.

Ventana Medical Systems’ Tool Helps Diagnose, Treat Rare Cancer
AZPM News – Nov 13, 2017
Ventana Medical Systems, has developed a tool that helps oncologists better diagnose and treat a rare form of lung cancer. Roche’s tool will help doctors identify a rare genetic mutation in patients with non-small cell lung cancer and target that marker, called anaplastic lymphoma kinase, with specially developed drugs.

Illumina Grows Clinical IVD Portfolio with Introduction of NextSeq(TM) 550Dx System and Expanded Use of MiSeq(TM) Dx System
Business Wire – Nov 15, 2017
Illumina, Inc. announced the introduction of its NextSeq™ 550Dx instrument, the company’s second FDA-regulated and CE-IVD marked next-generation sequencing (NGS) system. The company also announced that the intended use for the MiSeq™Dx instrument has been updated to include the use of DNA libraries generated from formalin-fixed paraffin embedded (FFPE) tissues, paving the way for clinical labs to use FFPE samples when developing clinical tests for new applications.

Edico Genome Announces New Offering: Comprehensive Clinical Genomics Information System
Markets Insider – Nov 16, 2017
At the Association for Molecular Pathology’s 2017 Annual Meeting (AMP), Edico Genome announced a new offering: the comprehensive DRAGEN Clinical Genomics Information System (CGIS). DRAGEN CGIS encompasses sample accessioning, lab tracking, secondary analysis of next-generation sequencing (NGS) data, tertiary analysis of NGS data, electronic medical record (EMR) integration, test kit.

Dana-Farber Team Developing MicroRNA Liquid Biopsy to Diagnose Ovarian Cancer
Genome Web – Nov 14, 2017
Researchers from the Dana-Farber Cancer Institute and Brigham & Women’s Hospital are developing a liquid biopsy assay that analyzes circulating microRNA to try and come up with a better method for diagnosing early-stage ovarian cancer.

Regulatory and Reimbursement Updates

Myriad Genetics Collaborates with CareFirst BlueCross BlueShield on Coverage with Evidence Development (CED) Study for the Vectra DA Test
Nasdaq – Nov 6, 2017
CareFirst BlueCross BlueShield (CareFirst) and Myriad Genetics, Inc. announced that they have signed an agreement to collaborate on a clinical utility study for the Vectra® DA test in patients with rheumatoid arthritis (RA).

Roche Receives FDA Approval for VENTANA ALK (D5F3) CDx Assay to Identify Lung Cancer Patients Eligible for Treatment with Roche’s ALECENSA (alectinib)
PR Newsire- Nov 7, 2017
Roche announced it has obtained US Food and Drug Administration (FDA) approval for the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Roche medicine ALECENSA® (alectinib). The VENTANA ALK (D5F3) CDx Assay is the only test FDA-approved as a companion diagnostic for ALECENSA.

OmniSeq Receives CAP Accreditation and Publishes Analytical Validation Paper
Nasdaq – Nov 9, 2017
OmniSeq, Inc. announced that it received accreditation by the College of American Pathologists (CAP), meeting the highest standard in excellence in clinical laboratory practices. The company also announced the publication of its analytical validation of a next-generation sequencing (NGS) immune response assay in the Journal of Molecular Diagnostics.

Roche Gets FDA Clearance for Colorectal Cancer IHC Panel
360 Dx – Nov 14, 2017
Roche announced that the US Food and Drug Administration has granted clearance for its Ventana MMR IHC panel, which provides clinicians with “a comprehensive group of immunohistochemistry tests” for patients diagnosed with colorectal cancer.

LabCorp Announces New Expanded Use for PD-L1 Test with Bristol-Myers Squibb’s OPDIVO
Business Wire – Nov 15, 2017
LabCorp announced the U.S. availability of the PD-L1 IHC 28-8 pharmDx assay as a complementary diagnostic for two newly approved indications in connection with the use of Bristol-Myers Squibb’s OPDIVO® (nivolumab) to treat patients with metastatic urothelial carcinoma, also referred to as bladder cancer, and squamous cell carcinoma of the head and neck.

Key Partnerships and Collaborations

Natera, Aarhus University Collaborate on Liquid Biopsy Study for Colorectal Cancer
Genome Web – Nov 6, 2017
Natera will collaborate with Denmark’s Aarhus University on a research study evaluating circulating tumor DNA as a biomarker to detect residual disease, treatment response, and disease recuurence in colorectal cancer patients.

CureOne Announces Partnership With Washington University to Advance Cancer Research
Digital Journal- Nov 8, 2017
CureOne™ (formerly known as MED-C) has formed a key partnership with Washington University School of Medicine in St. Louis. CureOne will work with the institution’s clinical Next Generation Sequencing laboratory, Genomics and Pathology Services (GPS), to unlock precision medicine and achieve the goals of the N1 Registry™, a revolutionary open-access database that links next-generation sequencing data with information about treatments and clinical outcomes.

U.S. Dept. of Veterans Affairs Renews and Expands Cancer Testing Contract with Personal Genome Diagnostics
PR Newswire – Nov 10, 2017
Personal Genome Diagnostics Inc. (PGDx) announced the renewal and expansion of its cancer genome testing contract with the U.S. Department of Veterans Affairs (VA). The contract includes PDGx’s CancerSELECT™ 125 tissue and PlasmaSELECT™64 liquid biopsy profiling panels. Both are comprehensive, clinically actionable pan-cancer genome tests that include assessments of microsatellite instability (MSI), a biomarker used to determine patient response to certain cancer immunotherapies. The new agreement expands the company’s existing contract to all VA facilities nationwide.

Clearbridge BioMedics and Leica Biosystems to Co-market Automated Solutions for Circulating Tumor Cell (CTC) Analysis
Markets Insider – Nov 15, 2017
Clearbridge BioMedics and Leica Biosystems have announced a partnership, co-marketing each other’s products to support circulating tumor cell (CTC) research. This is specifically for the Clearbridge BioMedics ClearCell® FX CTC enrichment system and the Leica Biosystems’ BOND RX staining platform.

MDxHealth Inks Distribution Deal for SelectMDx Prostate Cancer Test in Spain
Genome Web – Nov 20, 2017
MDxHealth announced today that it has signed a distribution deal for its SelectMDx for Prostate Cancer test in Spain with pharmaceutical company Ferrer.

Research and Clinical Validation Updates

Multiple Genetic Alterations Uncovered in Advanced EGFR-Mutant Lung Cancer Patients
Genome Web – Nov 6, 2017
Most patients with advanced EGFR-mutant lung cancer also harbor key secondary mutations within their tumors, according to a new study.

Guardant Health Database Reveals Potential of Targeted Therapy Combinations to Treat Advanced Lung Cancer
PR Newswire- Nov 6, 2017
Research led by scientists at UC San Francisco and the Francis Crick Institute in London has used Guardant Health’s database of comprehensive liquid biopsy results to demonstrate that combinations of targeted therapies should be studied in the treatment of certain advanced lung cancers.

Circulating Tumor Cells Associated with Relapse in Late-stage Melanoma Patients
EurekAlert – Nov 7, 2017
A study revealing a connection between circulating tumor cells (CTCs) and relapse in stage IV melanoma patients points to liquid biopsy as a potential predictor of patients at high risk for disease progression. CTCs, tumor cells shed into the bloodstream or lymphatic system, can lead to additional tumor growth and/or metastasis to distant sites.

Circulating Tumor DNA Quantification Method Helps to Select Patients for Liquid Biopsy WES
Genome Web- Nov 7, 2017
Researchers from several Boston-area institutions have developed a method to quantify circulating tumor DNA in a blood sample, allowing them to quickly identify which patients have high enough levels to allow for accurate genome-wide sequencing without the need to take a tissue biopsy.

New Research Reveals Molecular Heterogeneity of Metastatic Gastroesophageal Cancer
PR Newswire- Nov 15, 2017
Researchers from the University of Chicago, Dana-Farber Cancer Institute, and Guardant Health, Inc. published new evidence of the genomic heterogeneity of advanced gastroesophageal cancers (GEA). The study suggests that patients with these cancers could benefit from targeted therapy based on the detection of biomarkers found with a comprehensive liquid biopsy, but that were absent from their primary tumor.

Tempus Announces Latest Immunotherapy Project
Nasdaq – Nov 15, 2017
Tempus, along with Georgetown Lombardi Comprehensive Cancer Center, in Washington, D.C., and John Theurer Cancer Center at Hackensack Meridian Health Hackensack University Medical Center announce a new research collaboration aimed at identifying which patients will respond positively to immunotherapy treatment, the next generation of cancer care.

Study Analyzes Mutations in Cerebrospinal Fluid in Lung Cancer with Brain Metastases
Medical Express – Nov 17, 2017
Researchers have explored the analysis of mutations in cerebrospinal fluid of lung cancer patients with brain metastases in a study presented at the ESMO Asia 2017 Congress.

ctDNA Predicted Early Relapse in Resected Stage II/III Melanoma
Cancer Network – Nov 18, 2017
Levels of circulating tumor DNA (ctDNA) predicted worse outcomes including relapse and survival in patients with resected stage II/III melanoma, according to the results of a study published in Annals of Oncology.

Commercialization Milestones

NeoGenomics Europe S.A. Opens its Doors in Rolle, Switzerland Laboratory Hosting Business Leaders, Dignitaries and Local Government Officials
EIN NEWSDESK- Nov 9, 2017
NeoGenomics Inc. opened the doors of its new Rolle, Switzerland facility on Wednesday, November 8th to bring its unique Pharma Services offering to the global research community. Rolle was chosen as NeoGenomics’ European Headquarters because of the existing talent pool, favorable business environment, and proximity to leading academic institutions in Geneva and Lausanne.

Aus and NZ Oncologists can Provide Personalized Cancer Treatments using Caris Molecular Intelligence
MILTECH – Nov 14, 2017
Precision Oncology will be the new exclusive distributor for Caris Molecular Intelligence in Australia and New Zealand. Caris Life Sciences provides a comprehensive genomic tumour profiling plus (CGP+) of DNA, RNA and proteins enabling personalised therapy decisions across immunotherapy, targeted therapy and chemotherapy.

Biodesix Announces New Data Demonstrating Analytic Validity of Automated RNA Extraction from Plasma with the GeneStrat Test
Nasdaq- Nov 16, 2017
Biodesix® announced data demonstrating that a novel, automated method for extracting circulating RNA from plasma performed equivalently or better than the established manual method that is currently used for the company’s GeneStrat® test.

Guardant Health Expands Support for the Development of the GuardantOMNI(TM) Assay Through New Agreement with Bristol-Myers Squibb
PR Newswire- Nov 16, 2017
Guardant Health has added Bristol-Myers Squibb Company to the group of pharmaceutical companies it is working with to develop the GuardantOMNI assay, a 500-plus-gene liquid biopsy panel designed to accelerate clinical trials and the research of targeted cancer drugs and immunotherapies.

LabCorp Reports New Use of Agilent’s Cancer Diagonstic Test
Zacks Equity Research- Nov 17, 2017
LabCorp recently announced that Agilent’s Dako pathology division’s development — the PD-L1 IHC 28-8 pharmDx assay — is now available in the United States for new expanded use.

Expert Taskforce Recommendation of OncoBEAN(TM) RAS XRX Liquid Biopsy Testing in Routine Clinical Practice for Colorectal Cancer Patients
PR Newswire – Nov 21, 2017
Sysmex Inostics is pleased to highlight an expert taskforce review of the incorporation of BEAMing technology liquid biopsy testing in routine clinical practice for the management of colorectal cancer (CRC) patients. Sysmex Inostics launched the OncoBEAM™ RAS CRC CE Mark IVD Kit in 2016 as part of a global collaboration with Merck KGaA.

Funding

Personal Genome Diagnostics has raised $65 million in ongoing equity financing round in which it hopes to raise $111.5 million. The round has not yet closed.

Legal

Vigo seeks about $1.4 million from Nantworks
Markets Insider – Nov 3, 2017
The Vigo County Redevelopment Commission on Friday filed a lawsuit against Nantworks Terre Haute LLC alleging breach of contract due to failure to create jobs.

Caris Life Sciences Files Patent Infringement Suit against Foundation Medicine, Inc.
PR Newswire- Nov 7, 2017
Caris Life Sciences announced that the Company has filed a patent infringement suit against Foundation Medicine, Inc. in the United States District Court for the District of Massachusetts Boston Division. Caris is seeking damages and other relief for Foundation’s willful infringement of Caris’ patent rights by its FoundationOne®, FoundationACT® and FoundationOne® Heme products.

 

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